What is Market Complaint in Pharmaceutical?

DEFINITION

A complaint is any expression of dissatisfaction with a product or service marketed. Any written/ genuine verbal communication received directly from any customer, retailer, distributor, healthcare professional, regulatory agency, patient (Consumer) or field staff, regarding the safety, identity, strength, purity, efficacy, quality, shortages or any other such complaints shall be considered as a Market Complaint.

PROCEDURE

• All market complaints shall be received by the marketing department (Domestic/International) at the Head Office.
• The concerned marketing person shall record all the details of the complaint product, name and address of the complainant and nature of the complaint in "The Market Complaint Form and forward the same to Head-CQA.
• Head-CQA/Designee shall ensure all information in the "Market Complaint Form" concerning the particular complaint. Ensure that all required information is entered and all the necessary information for complaint investigation is received and if not, then Head-CQA shall ask to send the information needed to the marketing department.
• In case of quality/efficacy-related complaints, the Head-CQA/Designee shall request the complainant/marketing department for a complaint sample. Head-CQA/Designee shall follow up for complaint sample up to 15 days from the date of complaint.
• If the marketing department is unable to provide the required information (Details of complaint) and complaint sample to Head-CQA then the same complaint shall treat as a non-justified complaint and closed.
• If the required information is provided by the marketing department/complainant, Head - CQA shall acknowledge the “Market Complaint Form” by signing on received by column with date and the same shall be forwarded to Head-QA/Designee at the site.
• Head-QA/Designee shall enter the complaint details in the market complaint log.
• After logging of complaint, the Head-QA/Designee shall start the investigation of the complaint based on the guidelines provided.

Sr. No.	Example of Complaint	Suggested investigation
1.	Ineffectiveness / Poor Quality / Inadequate response of the drug product.	History of the product. Physical inspection of complaint & control sample. Review of batch document for, API calculation. Qty. added of API & excipients (dispensing slip/raw material requisition against bill of material. Source of material. Dispensing precautions: e.g. API dispensing & storage in the dedicated polybag or container etc. Processing precautions, low light, and nitrogen flushing or any other. Processing parameters. In-process checks by production & QA. Any deviation has a direct or indirect impact on product quality. In-process quality control data. Review of FP analytical report & trend. Review of stability data. Complaint & control sample analysis for, Weight variation, Hardness & friability. Content uniformity. Dissolution. Assay. Degradation. Moisture content. Biological assay. Storage condition. Audit of distributors, C & F agent or retailer etc.

Sr. No.	Example of Complaint	Suggested investigation
2.	Less content in capsules/ tablet	Physical inspection of complaint & control sample, For, Minor crack. Improper sealing. Condition of container label & / or carton to eliminate the possibility of leakage. Review of batch manufacturing record for, API calculation. Qty. added of API & excipients (dispensing slip/raw material requisition against bill of material. In-process checks by production & QA. Yield & reconciliation of the batch. In process & FP quality control data. Equipment usage logbooks of compression or capsule filing machine for breakdown. Complaint & control sample analysis for, Average weight Dissolution. Content uniformity. Assay. Degradation. Weight variation.

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Sr. No.	Example of Complaint	Suggested investigation
3.	Bulging of strip/blister pockets.	History of the product. Physical inspection of control & complaint sample. Review of storage condition. Review of stability data. Analysis of complaint &/or control sample for, Assay. Degradation.
4.	Presence of foreign matter (Living / non-living).	History of the product. Physical inspection of complaint & control sample. Physical inspection of particular AR No. of RM used for manufacturing of the batch. Review of batch manufacturing record. Cleaning record of mfg equipment & area. Environmental monitoring data. Analysis of complaint sample for, Assay, Degradation. Microbial contamination test. Training record of visual inspectors.
5.	Adverse reactions (e.g. vomiting, severe cramps, rashes etc)	Review of complaint history. Review the history of the patient. Review of the package insert. Microbiological analysis of complaint sample. Pharmacology of the API & related formulations.
6.	Discoloration of tablets/capsules.	History of the product. Physical inspection of complaint & control sample Review of batch manufacturing record for, Special precautions are required during processing e.g. controlled humidity/ light sensitivity & temperature etc. Cleaning record of granulation, compression, and coating equipment & area. In-process checks by production & QA during manufacturing & packing. Analysis of control & / or complaint sample for, Assay, Degradation, Stability data Storage condition.
7.	Damaged / broken / leakage in capsule	Physical inspection of complaint & control sample. Review of batch manufacturing record for, Visual inspection record Temp. & humidity conditions Capsule filling machine setting parameters In-process checks during manufacturing & packing by QA & production. Vendor of EHG capsule. Equipment logbook of capsule filling machine for breakdown. Training of the visual checkers. Compatibility study of empty hard gelatine capsule with excipients.
8.	Broken Tablet	History of the product. Physical inspection of complaint & control sample. Review of batch manufacturing record for, In-process checks by production & QA during manufacturing & packing. Visual inspection record. Review of a trend of processing, in process & FP Parameters and Handling of the bulk product. Training record of the visual checkers & strip/blisters

Sr. No.	Example of Complaint	Suggested investigation
9.	Product or batch mix-up.	Physical inspection of control & complaint sample for physical appearance of primary pkg. material of two products under question. A review of the system was followed to ensure proper segregation of products at different stages. Review of logbooks of machine at every stage to know the previous or next product taken on the same machine & precautions taken to ensure absence of same /similar product in the surrounding area. Review of other products packed on the same day on the nearby labelling machine or packing line of product under question. Review of batch manufacturing record for, Machine & line clearance record at different stages. Reconciliation of packaging materials. Reconciliation of bulk & FP. Analysis of control &/or complaint sample for, Identification test of two products under question. Identification test of preservative. Wrong labeling/ packing. Training record of checkers and packers.
10.	Poor quality of cap	History of the production Physical inspection of control & / or complaint sample. Vendor of packing (cap) material. Compatibility study Review of stability data.
11.	Faulty product (Product Counterfeiting)	History of the product. Comparison of complaint sample with control sample fo appearance of strip/ label (font size of letters, printed text matter, size of the pocket, gap between the two pockets, knurling pattern, logo of the company, movement of tab or cap in the pocket etc). Comparison of complaint sample with control sample fo appearance of tablet or capsule (size or dimensions, colour, imprint, embossing, edge type etc). Analysis of complaint & / or control sample.

Sr. No.	Example of Complaint	Suggested investigation
12.	Empty primary container (Bottle / pocket of strip or blister)	Physical inspection of control &/or complaint sample. Logbooks of striping or blistering machine for breakdown. Working of Non-Fill Detector (NFD) or Blister Inspection system (BIS) Review of batch document for, In-process checks by production & QA during filling. Leak test record. Visual inspection record. In-process checks by production & QA during packing (e.g. on line compressed air flow or any other system followed to remove empty plastic container or empty pocket in strip or blister). Yield & reconciliation of the batch & comparison with trend. Balance or check weigher performance & calibration check record. Weight variation record of packed cartons &/or shippers. Proper segregation of packed & empty boxes. Training record of the visual inspectors.
13.	Receipt of product in different cartons/ having different labels.	Complaint sample observation. Physical inspection of control sample. Previous & next product packed on the same machine. Appearance of packing material of two products under question. Review of batch document for, Line clearance (by packing & QA) record. Reconciliation of packing material. Machine & line clearance record. In-process checks by packing & QA. Storage of packing material in the store & in pkg. Dept. Procedure to be followed for the left over pkg. Material after completion of packing. Inspection of remaining stock of PM of the products under question. Training of checker and packers.

Head-QA/Designee shall write the complaint product details and categorize the complaint as Critical/Major/Minor in "Market Complaint Investigation Form

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Critical Complaint

A complaint that strongly indicates the purity, identity, safety or efficacy of a product may have been compromised and has the potential to cause a life-threatening or serious health situation.

Major Complaint

A complaint that indicates the purity, identity, safety or efficacy of a product may have been compromised but does not present as a life-threatening or serious health risk.

Minor Complaint

A complaint that is neither critical nor serious.

• If the complaint is categorized as critical, Head-QA shall intimate (within 24 hours from the receipt of the complaint) to Head - Marketing/Distribution for the immediate stoppage of the further sale and distribution of the batch till the completion of the investigation.
• Head-CQA / QA shall communicate to FDA / Regulatory Affairs / Customer / MA holder / QP / Customers regarding market complaints based on the nature of the market complaint.
• The investigation shall be carried out by a team of representatives from QC, QA, Production, Engineering, R&D, ADL, Marketing, RA and etc. (as per nature of the complaint).
• The investigation shall involve, but not restricted to, examining reserve samples, complaint samples and other samples, review of batches of complaint product, review of batch documents and other related logbooks and documents etc.
• If a complaint sample is received along with the market complaint, it should be thoroughly examined for the integrity of the pack, physical appearance and evidence of deterioration if any. The complaint sample needs to be checked for the detection of counterfeiting. Check for the counterfeit sample shall be carried
• out in accordance with the title outline in this SOP as “Handling of Counterfeit Samples”.

• In case of a quality testing-related complaint, QA shall send the complaint sample (if available) or reserve a sample of the complaint batch to the quality control department for analysis.
• Depending on the nature of the complaint, the reserve sample and complaint sample is to be analyzed for the relevant test parameters specified by Head-QA. Analysis of the sample is to be carried out as per the specification by which the product was registered.
• After completion of the analysis, QC shall send the analytical report to QA for further investigation.
• The Head-QA/Designee shall review the analytical report for compliance to specifications that may be
• relevant to the complaint.
• If the results of reserve samples and complaint samples are complying with the specification or either of the samples complies with the specification, probable root cause shall be identified.
• If any OOS is observed in the control samples, then investigate as per "OOS" SOP for Handling Out of Specification (OOS).
• QA shall ensure the storage of the remaining complaint sample in a secured manner under desired storage conditions till the closure of the complaint.
• Complaint samples received shall be destroyed during of closure of the complaint.
• Head - QA shall decide on the extension of the investigation if similar complaints for the product or other products have been received.
• Head - QA shall form an Investigation team, comprising of technical persons from requisite departments such as QA, QC, Production, Stores, Engineering, R&D, ADL, RA and Marketing depending upon the nature of the complaint.
• The investigation team shall investigate the complaint to identify the root cause and to take the necessary CAPA.
• For investigation methodology/tools SOP “Failure Investigation and Root Cause Analysis” and for CAPA SOP for Corrective Action and Preventive Action (CAPA) can be followed. 
• The complaint investigation may include the concerned Analytical Report, Batch Manufacturing Record, Batch Packing Record, instruments/equipment logbooks, Training Records, Stability Records, Cleaning Records, Calibration records, Environmental Monitoring Records of various stages of processing, Storage, Dispatch and distribution of the batch and other related documents such as any deviation in concerned batch.
• Previous and next batches of the product shall also be investigated in case of same raw materials/packing materials are used for the batch.
• The investigation shall extend to other batches of the same drug product and other drug products if the investigation shows the possibility of similar defects in other batches/products.
• If required, observations of stability study samples and review of data to be carried out.

• If required, help of R&D - Formulations shall be taken in case of process-related problems.
• Take Medical department opinion (if any) from medical experts as a part of the investigation for clinically related complaints.
• The investigation team shall identify the root cause of the complaint based on the observations made during the investigation.
• Manager-QA shall summarize the findings in the “Market Complaint Investigation Form” and the same shall be forwarded to Head-QA for impact assessment as per the root cause identified.
• Head-QA and other members of the investigation team shall suggest corrective and preventive actions against the identified root cause and the investigation report shall forward to Head-Manufacturing.
• Head-Manufacturing shall review and recommend suggested corrective and preventive actions.
• Finally, Head-QA shall review and approve the investigation report and CAPA. In case the investigation reveals the nature of the complaint as Critical, Head-QA shall initiate a recall of the complaint batches which exist in the market as per “SOP for Product Recall”.
• Head-QA/Designee shall send the investigation report to all concerned persons with the corrective and preventive actions in detail along with target completion date of actions.

TIMELINES FOR INVESTIGATION

• The investigation shall be completed within 7 working days for critical complaints and 30 working days for Major/Minor (or as per Technical Agreement requirement or Regulatory Agency requirement where appropriate) and same shall be sent to the marketing department immediately after investigation.
• If the complaint is from a regulatory agency / MA holder, the investigation shall be completed according to their timelines.
• Approved Market Complaint Investigation report shall be forwarded to the Marketing department, who in turn sends a response to the complainant.
• In case of complaints from the export market, QA/RA shall check the regulatory impact. While reviewing the impact, QA/RA shall consider the specific requirements mentioned in Technical Agreement as well as country-specific requirements.
• Wherever applicable, the regulatory agency / MA Holder / QP shall be informed if action is being considered following possible faulty manufacturing, product deterioration, detection of counterfeiting, or any other serious quality problems with a product that could result in a recall or abnormal restriction on supply.

• The corrective and preventive actions for all the complaints shall be tracked as per the SOP “Corrective and Preventive actions”.
• The acknowledgment from the complainant for the receipt of the response shall be obtained against the “Letter of Acknowledgment”. If the complainant provides acknowledgment through email/letter / fax, the same shall be documented.
• The complaint shall be treated as "Closed" after receiving feedback from the MAH/Customer/Complainant. The time period for receiving feedback from the customer is 30 days.
• If no further query is received within the stipulated time, the complaint shall be treated as closed. The closure details shall be recorded in “Market Complaint Closure Form”.
• Implementation of suggested corrective and preventive actions shall be verified by Head- QA/Designee.

• The Designated QA person shall ensure that all correspondence related to a complaint is available at the site before the closure of the complaint. Correspondence if made by the Marketing department / Medical department shall also be requested from the respective department.
• In case of receipt of any complaints through a legal route, the investigation findings shall be communicated by legal department in consultation with Head – of Quality / QA. 

Handling of Counterfeit Samples

• In case the received complaint samples are suspected to be counterfeit, then it shall be examined as follows:

1. In Comparison of packaging/labeling of the complaint sample with reserve sample.
2. Check the coding style/printing of the batch details.
3. Quality of the packaging components.
4. Organoleptic properties of the drug in comparison with reserve sample.

• If the comparison of the packaging components, coding style, and organoleptic examination does not reveal conclusive evidence then perform the analysis of the complaint sample along with reserve samples.
• During the course of an investigation, if the complaint sample received found to be counterfeit then Head-QA shall inform to marketing representatives in countries where the company's products are marketed for appropriate action through Head-CQA.
• In case of a counterfeit complaint, put a relevant remark in “Market Complaint Log” and in “Market Complaint Investigation Form” and close the complaint.

REVIEW AND TRENDING OF COMPLAINTS

• Head - QA shall review the complaint status every quarter to evaluate specific or recurring problems which require further attention.
• Designated QA person shall prepare complaint yearly trends. Trends shall be reviewed by Head- QA and required action shall be taken accordingly.
• The records of all market complaints for drug products and the follow-up / related records shall be kept for one year from the date of expiry of the batch for which the complaint has been received.

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